Novartis Blood Pressure Medication Runs into Trouble
by Gary Pepper, M.D.
Editor, Metabolism.com
In 2007 a new type of blood pressure lowering medication was brought to market by Novartis Pharmaceutical Company. This medication by the brand name Tekturna (aliskiran) works by blocking hormones that make up a circuit from the kidney to the blood vessels know as the RAAS system. This mechanism is distinct from all other blood pressure lowering medications available. By working via a completely novel pathway to lower blood pressure doctors were given another potent weapon in the war on high blood pressure. A second medication, Valturna, which combines an established blood pressure medication with Tekturna, was released by Novartis to the public in 2009. These drugs have been extremely popular due to their effectiveness and apparent freedom from serious side effects.
A warning about this class of drug was issued by Novartis, 2 weeks ago when it was forced to end the Altitude drug study due to apparent unforeseen complications in patients using Tekturna and Valturna. The study found a small but significant increase in stroke in diabetics with renal disease who were using these drugs. Although the group of patients in the Altitude study are up to 12 times more likely to develop stroke or heart attack under normal circumstances, Novartis had no choice but to end the study and issue a warning to the health care community about limiting the use of these drugs.

In my own practice I have found Tekturna and Valturna to be extremely effective and well tolerated. A survey of my colleagues revealed the same findings. Diabetes and high blood pressure very commonly occur together and national guidelines stress the need for excellent blood pressure control for diabetics to help prevent heart, kidney and eye complications of this disease. For doctors treating diabetics who recognize these patients as particularly high risk, having to significantly cut back or eliminate the use of Tekturna and Valturna is creating major concerns. Within the past week I have had to counsel numerous individuals about these issues and the solution is far from easy. For instance, one man with diabetes and early kidney disease and heart disease, with borderline high blood pressure despite using 4 different types of blood pressure medication including Tekturna has to decide with me, which is the greatest risk, going off the medication resulting in a rise in his blood pressure or continuing a drug which may pose a risk of its own.

These discussions are going on in doctor’s offices throughout the country with no good solution in sight. The only certainty is a flood of ads by lawyers which begin, “Have you ever been on Tekturna or Valturna….”.

One of the biggest problems with weight loss programs and diets is that even if they work the weight tends to come back on within a year or two. A recent study from the University of Utah of people who underwent bariatric surgery shows that not only do they lose weight quickly, after 6 years they continue to maintain their lower weight. After undergoing bariatric surgery the average weight drop was 35% of the original weight and after 6 years weight loss was still a very encouraging 28%. 75% of diabetics who had bariatric surgery were able to go off their diabetic medications, while improvements were generally seen in cholesterol levels and blood pressure.

Although this study shows a very high success rate, in the real world medical practice I have seen many people who are able to eat their way out of weight loss success after bariatric surgery. Eating small amounts of very high calorie food is still possible and unfortunately is not all that uncommon. Not to say that bariatric surgery is not helpful, because when it works the results can be spectacular, but as always the degree of motivation of the patient is crucial to success.

As a culture we don’t plan for a sudden halt in scientific advancements. Our tendency is to expect progress to be rapid and continuous. My prediction is that in certain areas of medical science we are likely to see not only a halt in progress but a slipping backward. In particular, the realm of medical weight management is in complete disarray at this time. Two new drugs designed to induce weight loss have been shot down by the FDA in the last few months. The first is Qnexa, developed by Vivus Inc. Interestingly, Qnexa combines two drugs already approved for use in the U.S. One of the drugs is phentermine which is a medication used for decades as an appetite suppressant. The other is a common drug used to treat seizures with the brand name Topamax (topiramate) which also induces weight loss. The drug performed admirably in clinical trials with most participants losing over 10% of body mass. The FDA cited excessive risks of the drug in its statement of rejection. One wonders why the drugs are still being marketed separately if they are so dangerous.

The latest drug to be rejected by the FDA is Lorgess (lorcaserin), developed by Arena Pharmaceuticals. This drug, not as effective as Qnexa, produced 5% body mass loss in about half of participants in clinical trials. Lab animals showed a tendency to develop breast tumors when exposed to the medication, adding to the FDA’s decision to reject the drug application based on safety concerns.

I am a strong advocate of drug safety and regulation. On the other hand we know obesity, and with it Type 2 diabetes, is epidemic in the U.S. I regard weight loss as the “holy grail” when treating type 2 diabetes and yet it is the most difficult goal to achieve. Any drug which could assist in weight loss is highly desirable in the treatment of Type 2 diabetes. Not only does blood sugar improve with weight loss but also blood pressure and cholesterol readings show declines. All three of these parameters are known to be prime contributors to the main cause of death in diabetics, cardiovascular disease.

It has already been 10 years since the last drug was approved specifically for a weight loss indication. The failure of these two latest medications to achieve approval is certain to cause the pharmaceutical industry to severely curtail if not abandon further investment in this type of drug development.

Why is the FDA so reluctant to approve a weight loss pill? This is a complex issue but requires an answer. A new weight loss inducing medication is certain to be highly anticipated and widely prescribed. Therefore, from the very first day of approval the FDA must take responsibility for the well being of millions of people who are likely to take the medication. We are a society which demands our medications deliver miraculous cures with no side-effects. If someone perceives they have been injured by a medication our legal system is primed to unleash brutal retribution on everyone remotely involved in the approval process. Abuse and injury with a medication designed to cause weight loss is almost a certainty. This is a no-win situation for the administration of the FDA.
I predict it will be at least another 10 years before a medication for weight loss is approved by the FDA. Unless there is a change in the climate of litigation in this country it will take longer than that. In the meantime the only new developments in weight loss drugs will be the result of exploiting appetite suppressant effects which are the “side-effect” of medications approved for other purposes.

It seems obvious that cutting away part of the stomach and intestine should cause weight loss. With a smaller stomach and less intestine fewer calories can be absorbed per day causing weight loss. Surgeons who perform gastric by-pass were puzzled however, by how fast their patients showed metabolic improvement after undergoing this procedure. They noticed many of their diabetic patients could be taken off diabetic medication immediately after surgery before weight had been lost. Scientists looking into this phenomena discovered unsuspected ways gastric by-pass improved metabolism.

The intestines produce hormones which regulate blood sugar and appetite. GLP-1 is among the best known of these intestinal hormones. GLP-1 is the basis of a whole new generation of medications used to treat diabetes such as Byetta, Victoza, Januvia and Onglyza. GLP-1 lowers blood sugar, stimulates the pancreas and reduces appetite. After gastric by-pass increased amounts of GLP-1 are produced by the remaining intestine. In a study published in the Journal of Clinical Endocrinology and Metabolism (95:4072-4076, 2010), researchers at St. Luke’s Hospital in New York discovered that levels of oxyntomodulin, another intestinal hormone that suppresses appetite and acts like GLP-1 on blood sugar levels, is doubled after gastric by-pass.

These exciting discoveries help explain why obese diabetics can often be sent home without any medication to control blood sugar immediately after undergoing gastric by-pass surgery. Although most insurance plans do not cover gastric by-pass surgery, dramatic improvements in patients after the procedure with greatly reduced medication costs may convince insurance companies that paying for the procedure will result in better outcomes and save them money in the long run.

After reading the latest research on the metabolic hazards associated with chubby necks I am more sensitive to the size of people’s necks then ever. Of course I look at the size of my patient’s neck but people who I pass in the street or supermarket may find me staring. Watching TV a few days ago I was startled by a series of people in one commercial for Quicken Loans who definitely qualify for the metabolic high risk category based on neck chubbiness. One after another the characters in this commercial walk on, outdoing each other in this physical trait. Has the chubby neck become the new normal? If so, the incidence of diabetes and heart disease is sure to continue to rise.

Let me know if you agree with my impression, or am I biased by being an endocrinologist?

Metabolism.com is pleased to share the following article provided by our guest contributor, Tom Hines.
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In some ways, your body is like a machine — it works best when it’s properly maintained and tuned up. Food is your fuel and when you fill your tank with lousy fuel, your engine sputters and stalls. If your body’s engine is sluggish and needs a jumpstart, spirulina and other green superfoods can help deliver the energy necessary to keep the machine running smoothly, avoiding a breakdown.

Spirulina is a ‘green superfood,’ a term used to describe various nutrient-rich natural supplements, which include Chlorella, Wheat Grass, Barley Grass, Alfalfa and Kelp. Unlike most store-bought supplements, the concentrated vitamins and minerals they provide are not synthetic. Green superfoods are whole foods harvested directly from nature and are exactly what your body needs to offset stress and to clear away toxins.

SAD is very sad indeed

S.A.D. stands for Standard American Diet – there was never a more apt acronym. The majority of U.S. citizens today subsist on processed fast food laden with refined carbohydrates and saturated fats. Meats are frequently tainted with growth hormones, antibiotics and pathogens. For people who manage to work the recommended five to nine daily servings of fruit and vegetables into their diet, modern agricultural techniques have stripped crops of many vitamins and minerals.

Processed and cooked foods, which are the cornerstones of the S.A.D, and beverages such as coffee, tea, soft drinks and alcohol create an acidic blood pH, encouraging the growth of bacteria, fungus and mold. In an overly acidic environment, the body literally begins to compost. Illnesses such as heart disease and diabetes are often the result of the composting process. Green superfoods have an alkalizing effect, counteracting the acidity caused by poor diet, stress and toxic overload and setting the stage for a return to good health.

Spirulina and Chlorella, the most super of the green superfoods

Spirulina is a blue-green algae whose name comes from its spiral coil shape. High quality spirulina thrives in both salt and fresh water in tropical climates and it is known to have nourished the Aztecs, who harvested the algae from Lake Texcoco. Some of the benefits of Spirulina are:

Contains all of the essential amino acids vital to human health

An excellent protein source for all vegetarians, including vegans

Balances blood sugar by boosting glycogen, which offsets insulin

Rich in GLA (gamma linolenic acid) and other essential fatty acids Delivers an array of vitamins, including the all-important folic acid

High in potassium and a dozen other minerals

Improves focus and mental clarity

Chlorella is a single-celled green algae whose name is derived from Greek and Latin words that translate to “little green.” In the 1940’s and 1950’s, intensive research was done on little green algae’s potential role in solving world hunger, due to its high protein content and its bounty of beneficial vitamins and minerals. The natural health community, meanwhile, has always touted Chlorella’s health-imparting properties, particularly in the area of detoxification. In addition to being the very best source of chlorophyll, here are some more of Chlorella supplement benefits:

Rids the body of toxins and stored waste

Tones and cleanses the blood

Reduces body odor, acting as an internal deodorant

Improves bowel health and reduces flatulence

Naturally freshens the breath

Clears the skin

Cereal grasses and seaweed

Wheat grass is a popular juicing ingredient due to its superior nutrition, which it delivers without raising blood sugar. It also helps to lower blood pressure.

Barley grass alkalizes the blood and strengthens the digestive system.

Alfalfa helps reduce LDL (low-density lipoprotein) or bad cholesterol, without affecting levels of HDL (high-density lipoprotein) or good cholesterol and studies are underway to determine its effectiveness at lowering blood sugar levels and its ability to invigorate the immune system.

Kelp is a brown-algae seaweed, which grows in abundant kelp forests in shallow oceans all around the world. Kelp is rich in iodine and therefore beneficial to overall thyroid health. Its high vitamin and mineral content promotes pituitary and adrenal gland health as well. It’s renowned for its contribution to lustrous hair and skin. Taken shortly after exposure, it can also mitigate the negative ramifications of heavy metals and irradiation.

Making the most of green superfoods

Incorporating Spirulina, Chlorella and other green superfoods into the diet is easy, since they are all available in powdered form. Simply mix the desired amount into salad dressing, or add it to soup, juice or water. The taste is fresh and green and the active enzymes of living food add a healthy dimension even to a less than healthy meal. Of course, pregnant or breastfeeding women and people taking medications should consult with their doctors before incorporating any new food into their diets.

Many people who regularly incorporate green superfoods into their daily regimen have reported increased energy, mental clarity and an overall healthy glow. When stress, toxic thoughts and an imperfect diet have left your body’s engine sluggish, green superfoods are a quick and easy way to put yourself back on the road to health. Long may you run!

About the Author
Tom Hines, co-owner of NutritionGeeks.com (MN #1 Now Foods herbal provider), has been working in the nutrition industry since 1997, is a competitive powerlifter, lives with his wife Netti and three boys TJ, Grady and Brock on the prairie in west central Minnesota, spends his leisure time coaching youth wrestling, working with his horses and being play toy #1 for his boys.

It’s over between me and Oprah. If you are a regular reader of metabolism.com you probably know about my proposal to Oprah. Don’t get worked up, it wasn’t a marriage proposal. It was a proposal to create a Diabetes Lifestyles reality show for her new cable network. Here’s the background. Oprah is starting her “Own” network on cable and is hosting a contest for ideas to add to her line up. For the past 6 months visitors to Oprah’s website have been able to view all the ideas submitted by the public and vote for their favorite ones. My idea was to produce a Diabetes Lifestyle reality show called This Sweet Life. Over two months my idea acquired about 60 votes and was still in the running. The problem between Oprah and I started when she asked for a commitment. I’m not phobic about commitments but she asked for too much. In order to stay in the contest I had to commit to taking 6 weeks away from my medical practice to go to Los Angles to participate in filming of the conclusion of the contest. I’m sorry Oprah…I’m already committed to my medical practice so you can’t have me!

What comes to mind when considering the term “inflammation”? A festering pimple, or perhaps a high fever, an infected tooth, toe, abscess? These are typical examples of inflammation. Inflammation may exist in many other forms however, including possibly obesity.

Inflammation describes the immune system when it is activated. The presence of pus or fever are obvious forms of this. More subtle forms of inflammation can exist in the body. Recently, researchers from Australia, presented evidence that obesity itself is associated with abnormal activation of the immune system, or in other words, inflammation. This inflammation might in turn, cause type 2 diabetes. It is already becoming clear that the inflammation associated with obesity contributes to insulin resistance, the first step in the development of type 2 diabetes. In a study just published in the June volume of the Journal of Clinical Endocrinology and Metabolism (95:2845-2850, 2010), patients with either type 2 diabetes or pre-diabetes were evaluated for the distribution of inflammatory blood cells before and after gastric band surgery. Abnormal immune activation or inflammation was detected in this group. After an average of 13% weight loss following gastric surgery, the scientists found up to an 80% reduction in inflammatory blood cells. Many of the patients were able to significantly reduce their diabetic medications after the weight loss. The conclusion is that inflammation may result from obesity and is reversible when significant weight is lost. Metabolic problems like diabetes improve as the inflammation is reduced, as well. Therefore, inflammation may be part of the reason people develop diabetes as their weight increases.

Studies like this will provide new avenues for attacking the development of type 2 diabetes due to excessive weight gain, and possibly to help find ways of combating obesity, as well.

Well….we tried. Thanks to everyone who voted for my Diabetes Show idea for the Oprah channel. With only 40 votes so far and 4 days to go, there isn’t much hope of my idea getting recognized by the judges for the Oprah network contest.

I still think it would be great T.V. to have a behind the scenes and personal look at the lives of people with diabetes and their relationships with their health care providers.

During the past decade researchers have discovered that lack of adequate sleep can cause metabolic defects similar to those of diabetes. Blood sugar tends to be higher and insulin resistance more pronounced in people who don’t get adequate sleep. To create these abnormalities in blood sugar metabolism for studies, researchers typically deprived subjects of sleep to an extreme degree for several days. Recent research however, showed that less drastic sleep deprivation can create the same diabetes-like problems in metabolism.

In a study just published in the June edition of the Journal of Clinical Endocrinology and Metabolism (95:2963-2968, 2010), researchers in the Netherlands allowed normal subjects to sleep for only 4 hours for a single night. They found that after one night of sleep deprivation the body was not able to respond nearly as well to insulin as after a normal night of sleep.

Can this type of sleep deprivation eventually lead to permanent blood sugar problems? A group of researchers from Columbia University found that people who habitually sleep less than 5 hours per night are twice as likely to develop diabetic levels of blood sugar compared to those who sleep more.

What is the connection between sleep deprivation and diabetes? The thought is that lack of sleep fosters an inflammatory environment in the body. Whether this is because during sleep the body removes inflammatory cells and toxins or whether sleeplessness increases the production of inflammatory agents is not known. Inflammation, in turn, creates the basic metabolic defect in type 2 diabetes known as insulin resistance. Since insulin is the hormone that regulates blood sugar, if the body is resistant to insulin than high blood sugar (diabetes) can develop.

Conclusion? Work and worry less, sleep better and longer, and reduce your risk of getting diabetes. (Did I hear you say he must be dreaming?)

This article is for educational purposes only and is not meant as medical advice or treatment.